Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-29 @ 6:53 AM
Study NCT ID:
NCT03532659
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2018-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Active Video Game on Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention with two comparison groups. The control or experimental group will be randomly defined by school\n\n* "Experimental" group: will perform physical activity through the use of the active videogame associated with a gamification strategy three times a week for 50 minutes for a period of 8 weeks.\n* Control group: there will be no intervention proposal, only used for data comparison.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-05-19', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microcirculatory blood flow during rest (RF)', 'timeFrame': '10 minutes', 'description': 'Variable measured in perfusion units (PU), obtained during the first five minutes of the microcirculation evaluation protocol by Cutaneous Laser Doppler Flowmetry (LDF).'}, {'measure': 'Maximum blood flow (MF)', 'timeFrame': '10 minutes', 'description': 'Peak blood flow during post-occlusive reactive hyperemia (PORH), expressed in perfusion units (PU).'}, {'measure': 'Area of hyperemia', 'timeFrame': '10 minutes', 'description': 'Scalar numerical variable corresponding to the geometric area related to the process of reflex hyperemia after the mechanism of arterial occlusion, expressed in perfusion units (PU).'}, {'measure': 'Relationship between peak flow during PORH and resting blood flow.', 'timeFrame': '10 minutes', 'description': 'Continuous variable, MF / RF ratio expressed in perfusion units (PU).'}, {'measure': 'PORH index', 'timeFrame': '10 minutes', 'description': 'Scalar numerical variable related to reactive hyperemia after the arterial occlusion. mechanism, expressed in perfusion units (PU)'}, {'measure': 'Occlusion area', 'timeFrame': '10 minutes', 'description': 'Scalar numerical variable corresponding to the geometric area related to the region without reflex hyperemia after the arterial occlusion mechanism, expressed in perfusion units (PU).'}, {'measure': 'Carotid Intima Media Thickness', 'timeFrame': '30 minutes', 'description': 'Variable measured in millimeters, obtained by the maximum value of 3 measurements performed in the right common carotid artery and 3 measurements in the left common carotid artery. Performed with a portable device (General Eletric®, LogicE® model), with a high definition linear transducer.'}, {'measure': 'Femoral Intima Media Thickness', 'timeFrame': '30 minutes', 'description': 'Variable measured in millimeters, obtained by the maximum value of 3 measurements made in the right femoral artery and 3 measurements in the left femoral artery. Performed with a portable device (General Eletric®, LogicE® model), with a high definition linear transducer.'}, {'measure': 'Cardiorespiratory Fitness - Maximum oxygen consumption', 'timeFrame': '10 minutes', 'description': 'Numerical, continuous, expressed in liters per minute per kilogram (l/mim/kg), obtained indirectly through the 20-meter run test.'}, {'measure': 'Flexibility', 'timeFrame': '5 minutes', 'description': 'variable numeric, continuous, expressed in centimeters, obtained through the sit-and-reach test.'}, {'measure': 'Abdominal resistance', 'timeFrame': '2 minutes', 'description': 'numerical, continuous variable, expressed in absolute number of abdominal performed in one minute, obtained through the sit-up test.'}], 'secondaryOutcomes': [{'measure': 'nutritional status', 'timeFrame': '10 minutes', 'description': 'measured weight (kilogram) and height (centimeters) for calculating body mass index, expressed in Kg/m\\^2.'}, {'measure': 'abdominal adiposity', 'timeFrame': '5 minutes', 'description': 'measurement of abdominal circumference with inelastic tape, in centimeters.'}, {'measure': 'Blood Pressure', 'timeFrame': '15 minutes', 'description': 'measurement blood pressure (mmHg) through digital tensiometer OMRON.'}, {'measure': 'Lung Function - Forced Expiratory Volume in the first second', 'timeFrame': '20 minutes', 'description': 'Evaluated by spirometry, with a computerized ultrasonic portable spirometer, with flow sensor, Easy One® brand, with internal Winspiro Software upgrade version 1.04 for connection to computer. The course will provide the values of Forced Expiratory Volume in the first second expressed in liters (l) and in percentage of the predicted value individually (%pred).'}, {'measure': 'Lung Function - Total Lung Capacity', 'timeFrame': '20 minutes', 'description': 'Evaluated by spirometry, with a computerized ultrasonic portable spirometer, with flow sensor, Easy One® brand, with internal Winspiro Software upgrade version 1.04 for connection to computer. The course will provide the values of Total Lung Capacity expressed in liters (l) and in percentage of the predicted value individually (%pred).'}, {'measure': 'Strength of the inspiratory and expiratory muscles', 'timeFrame': '20 minutes', 'description': 'Evaluated by digital manovacuometry, through a digital manovacuometer MVD300, will be obtained the measurement of respiratory maximum static pressures, maximum inspiratory pressure regarding inspiratory muscle strength and maximum expiratory pressure regarding the expiratory muscles. Both will be expressed in cmH2O.'}, {'measure': 'Fasting blood glucose', 'timeFrame': '5 minutes', 'description': 'Continuous numeric variable expressed in mg/dL.'}, {'measure': 'C-reactive protein', 'timeFrame': '5 minutes', 'description': 'Continuous numeric variable expressed in mg/dL.'}, {'measure': 'Total cholesterol', 'timeFrame': '5 minutes', 'description': 'Continuous numeric variable expressed in mg/dL.'}, {'measure': 'High density lipoprotein (HDL) cholesterol High density lipoprotein (HDL) cholesterol', 'timeFrame': '5 minutes', 'description': 'Continuous numeric variable expressed in mg/dL.'}, {'measure': 'Triglycerides', 'timeFrame': '5 minutes', 'description': 'Continuous numeric variable expressed in mg/dL.'}, {'measure': 'Glycated hemoglobin A1c', 'timeFrame': '5 minutes', 'description': 'Continuous numeric variable expressed in percentage (%).'}, {'measure': 'Low density lipoprotein (LDL) cholesterol', 'timeFrame': '5 minutes', 'description': 'Continuous numeric variable obtained by the Friedewald formula= Cholesterol Total - (High Density Lipoprotein + Triglyderides/5), expressed in mg/dL.'}, {'measure': 'Quality of life assessment', 'timeFrame': '20 minutes', 'description': 'application of validated questionnaire'}, {'measure': 'Food consumption', 'timeFrame': '20 minutes', 'description': 'application of validated questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescents', 'obesity', 'lung function', 'microcirculation', 'intima media thickness'], 'conditions': ['Overweight and Obesity', 'Cardiovascular Risk Factor', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of physical exercise through active videogame in the microcirculation, macrocirculation, cardiorespiratory function and physical fitness in overweight adolescents. For that, they will be randomized into two groups, one being a control group and the other intervention group. The randomization will be made by school. The intervention group will perform the physical exercise through the active video game, three times a week, for 50 minutes, during 8 weeks. Reassessments will be performed before and after the intervention to evaluate the outcome variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight or obese adolescent\n* Students enrolled in public schools\n\nExclusion Criteria:\n\n* Motor, cognitive or pulmonary limitation\n* Genetic syndrome\n* Pregnancy\n* Use of medication that changes the lipid or glucose profile\n* Not being treated for overweight'}, 'identificationModule': {'nctId': 'NCT03532659', 'briefTitle': 'Impact of Active Video Game on Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight', 'organization': {'class': 'OTHER', 'fullName': 'Professor Fernando Figueira Integral Medicine Institute'}, 'officialTitle': 'Impact of Active Video Game Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight: Randomized Intervention Study', 'orgStudyIdInfo': {'id': 'Active video game-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active video game', 'description': 'The adolescents will be submitted to physical activity with active video game for 50 minutes, 3 times a week, for a period of eight weeks. The XBOX360® platform will be used with the Kinect accessory (Microsoft®) and Just Dance will be the selected game. The music used for intervention will be previously selected, including those that can lead to moderate intensity, and assembled in blocks of 10. For each week, a new block and challenges must be elaborated to increase the motivation to carry out the physical activity.', 'interventionNames': ['Other: Active video game']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'A follow-up will be done for eight weeks to compare the variables. The adolescents in this group will be interviewed monthly to detect changes in eating habits and lifestyle.'}], 'interventions': [{'name': 'Active video game', 'type': 'OTHER', 'description': 'Among the 20 municipal schools, two will be selected between those with 298 or more students (corresponding to the third quartile of the number of students per school). Next will be selected the school in which the adolescents will be submitted to intervention, and the students from the other school will be control. The intervention will aim to promote physical exercise through active video game XBOX 360 with Kinect. The game selected will be Just Dance, to allow the participation of up to four students at the same time. In addition, a gamification protocol will be performed to increase the adolescents engagement in the exercise.', 'armGroupLabels': ['Active video game']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58415483', 'city': 'Campina Grande', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Escola Municipal de Ensino Fundamental Governador Antônio Mariz', 'geoPoint': {'lat': -7.23056, 'lon': -35.88111}}, {'zip': '58416336', 'city': 'Campina Grande', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Escola Municipal de Ensino Fundamental Tiradentes', 'geoPoint': {'lat': -7.23056, 'lon': -35.88111}}], 'overallOfficials': [{'name': 'Carla CM Medeiros, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Estadual da Paraíba'}, {'name': 'João Guilherme B Alves, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor Fernando Figueira Integral Medicine Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Professor Fernando Figueira Integral Medicine Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade Estadual da Paraíba', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctorate', 'investigatorFullName': 'Thacira Dantas Almeida Ramos', 'investigatorAffiliation': 'Professor Fernando Figueira Integral Medicine Institute'}}}}